Temozolomide Capsules — Class II drug recall D-0441-2017
Terminated recall by Mylan LLC., reported 2017-02-01, distributed nationwide. Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose po
| Recall number | D-0441-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan LLC., Caguas, PR, United States |
| Recall initiated | 2016-12-20 |
| Classified | 2017-01-25 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2018-01-25 |
| Distributed | Nationwide (US) |
| NDC | 00378-5262-14, 00378-5262-98 |
Product
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Reason for recall
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0441-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.